PROSPECTIVE RANDOMIZED EVALUATION OF EMERGING NOVEL TREATMENTS FOR INFECTION PROPHYLAXIS IN TOTAL JOINT REPLACEMENT (PREVENT-IT): A PILOT STUDY
Notice bibliographique
Résumé
Osteoarthritis (OA) is the most common cause of disability in older adults worldwide. Total Joint Replacement (TJR) is the definitive treatment for OA and can drastically improve functionality, decrease pain, and improve quality of life. Despite its success, there is a small but serious risk of infection following TJR. Periprosthetic Joint Infection (PJI) in particular is a devastating and costly complication, placing its prevention atop the list of priorities among both orthopaedic surgeons and the infectious disease community. Several different interventions aimed at reducing rates of PJI have been proposed and investigated; however, none have yet demonstrated definitive efficacy. The purpose of this pilot study was to determine the feasibility of a definitive randomized controlled trial (RCT) comparing the use of irrigation fluids and topical antibiotics to reduce the risk of reoperation due to infection. This pilot study was a 3x2 factorial RCT across six centers. Participants having primary or aseptic revision hip or knee replacement were randomized to one of six possible groups: 1) 0.35% povidone-iodine lavage; 2) 0.35% povidone-iodine lavage and 2 grams of local vancomycin; 3) 0.05% chlorhexidine gluconate lavage; 4) 0.05% chlorhexidine gluconate lavage and 2 grams of local vancomycin; 5) normal saline lavage; 6) normal saline lavage and 2 grams of local vancomycin in a 1:1:1:1:1:1 ratio. Participant follow-up is six weeks, six months and one year post TJR. A traffic light approach was used to interpret the main objectives, where “green” indicates move forward with the definitive trial with no modifications, “yellow” indicates proceed with some modifications, and “red” indicates that the definitive trial is not feasible. A total of 500 participants were recruited at six different sites over a recruitment period of nine months. There were 56% females and 44% males. The mean age was 67 (standard deviation [SD] 9.98). There were 261 (52%) knees and 236 (47%) hips included. A total of 480 (96%) of procedures were primary and 17 (3%) were aseptic revisions. The overall compliance to the protocol is 94% with 15/500 (3%) of errors due to the use of additional antiseptic irrigation solutions during surgery, 3/500 (0.6%) randomization errors, 2/500 (0.4%) incorrectly enrolled and 8/500 (1.6%) those who did not receive the study intervention. There are five periprosthetic joint infections requiring reoperation and five instances of post wound drainage with one requiring reoperation. We will proceed with the definitive RCT, as the traffic light approach indicates that both recruitment at multiple sites and the administration of the study treatments is feasible. To maintain the 3x2 factorial design of the pilot study we will simplify both the frequency of follow-up and the amount of data collected in the definitive RCT.
Récupéré en direct depuis OpenAlex et désinversé. Les résumés ne sont pas conservés dans cette base de données : les index inversés représentent 8,6 Go des 9,3 Go de texte de la base, et le serveur dispose de 13 Go libres.
Comment cette classification a été obtenuedéplier
Prédiction distillée sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Apprise à partir de 10 348 étiquettes directes de Codex et de 10 348 étiquettes directes de Gemma. Le mode candidate est l'union des têtes enseignantes seuillées; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont ni des étiquettes humaines ni des étiquettes directes de modèles de pointe.
Scores Codex et Gemma par catégorie
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,003 | 0,001 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,001 | 0,000 |
| Bibliométrie | 0,001 | 0,001 |
| Études des sciences et des technologies | 0,000 | 0,000 |
| Communication savante | 0,000 | 0,000 |
| Science ouverte | 0,000 | 0,000 |
| Intégrité de la recherche | 0,000 | 0,000 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,000 | 0,000 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découleClassification
machine, non validéePrédiction automatique; un appel candidat d’une seule tête enseignante, pas un consensus.
Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».